Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: ELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM
• Applicant: Staar Surgical Co.; 1911 Walker Ave.; Monrovia, CA 91016
• PMA Number: P900048
• Date Received: 07/02/1990
• Decision Date: 09/17/1991
• Docket Number: 91M-0376
• Notice Date: 10/11/1991
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Supplements: S001 S002